GuideAI Health is one of 16224 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
GuideAI Health - FDA 510(k) Cleared Devices
Recent clearances: Vascular Assist Occlusion Triage (VAOT) (v1.0)
1
Total
1
Cleared
0
Denied
GuideAI Health has 1 FDA 510(k) cleared medical devices. Based in Boston, US.
Latest FDA clearance: Jun 2026. Active since 2026. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by GuideAI Health Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Innolitics, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - GuideAI Health
1 devices